MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number	ZA9003
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Attempts have been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the doctor saw a rip in the intraocular lens (iol) when he went to insert the lens into the patient's operative eye.There was patient contact and the procedure was completed using a replacement lens.No further information was available.
Additional Manufacturer Narrative
Correction and additional information: b5: additional: subsequent follow up information received from the surgery center confirms that there was no patient contact.Additionally, there was no patient injury and no intervention was required.The procedure was completed using another lens of same model and diopter.Upon reviewing the complaint folder, it has been confirmed that there was no patient contact.Based on our reportable criteria, this report is no longer a reportable event.Therefore, an emdr is required to state that no further follow ups will be sent out under medwatch 2648035-2021-08214.Device evaluation: product evaluation was not performed because the product has not yet been received.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and no deviation was found related to the complaint issue reported.There was no discrepancy found during the review.The product was manufactured and released according to specifications.A search revealed one complaint which was coded for haptic damaged which is not related to the complaint issue of this investigation.Therefore, no escalations are necessary.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 12256196
• Report Number: 2648035-2021-08214
• Device Sequence Number: 14428393
• Product Code: HQL
• UDI-Device Identifier: 05050474528949
• UDI-Public: (01)05050474528949(17)241114
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2024
• Device Model Number: ZA9003
• Device Catalogue Number: ZA90030165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1